Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-29 @ 1:20 AM
Study NCT ID:
NCT05776550
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2023-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Distal Radial Approach (SAFE-BOX)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2023-03-08', 'studyFirstSubmitQcDate': '2023-03-08', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of examination and procedure', 'timeFrame': 'through procedure completion, up to 24 hours', 'description': 'Success rate of examination and procedure'}], 'secondaryOutcomes': [{'measure': 'the success rate of the puncture', 'timeFrame': 'through procedure completion, up to 24 hours', 'description': 'the success rate of the puncture'}, {'measure': 'puncture time', 'timeFrame': 'through procedure completion, up to 24 hours', 'description': 'puncture time'}, {'measure': 'complications of the puncture region', 'timeFrame': 'the first outpatient visit after discharge', 'description': 'complications of the puncture region'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety', 'Efficacy']}, 'descriptionModule': {'briefSummary': 'A Prospective Registry to assess the Safety and Efficacy of Distal Radial Approach', 'detailedDescription': 'Anaphylactic radial approach is now recognized as a basic technique in coronary artery procedures. The main advantage is increased stability due to the reduction of massive bleeding and increased patient comfort because it can move immediately after the procedure. The operator prefers access to the right radial artery because of the comfort of performing the procedure on the right side of the patient. However, the operator should frequently replace it with a left radial artery approach for various reasons, including 1) closure of the right radial artery, 2) difficulty accessing the coronary artery due to severe gambling of the radial artery, and 3) hemodialysis of the right radial artery.\n\nAs for prognosis, the left and right radial artery approaches are similar. However, the left radial artery approach is bound to experience anthropological discomfort in which the operator has to lean toward the patient. An easy solution is the approach from the anatomical left snuff box located on the back of the hand to the distal radial artery. Recently, the left snuffbox approach has been reported, and attempts are increasing in many countries. However, it is true that there is still a difference in diameter of the radial artery through the distant radial artery approach and concerns about percutaneous coronary intervention through this compared to the classical radial artery approach. Recent studies have published studies on the stability and effectiveness of distant radial artery approaches, but they are still small, and studies on specific subgroups are very scarce. Furthermore, data on the current status and performance in Korea so far is very scarce. Therefore, through this study, we would like to systematically collect and analyze data on the status and performance of the approach through the distant radial artery approach to find out the stability and effectiveness of various patient groups, treatment methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Evaluate the success rate of coronary angiography and intervention in patients with palpable radial artery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients over 20 years of age\n2. Patients requiring coronary angiography or intervention\n3. Patients with palpable distant radial artery\n\nExclusion Criteria:\n\n1. Patients with distant radial artery too small or not palpable\n2. Pregnant women\n3. Patients not appropriate for the researcher to judge'}, 'identificationModule': {'nctId': 'NCT05776550', 'briefTitle': 'Safety and Efficacy of Distal Radial Approach (SAFE-BOX)', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'A Prospective Registry to Assess the Safety and Efficacy of Distal Radial Approach (SAFE-BOX)', 'orgStudyIdInfo': {'id': '9-2021-0048'}}, 'contactsLocationsModule': {'locations': [{'zip': '16995', 'city': 'Yongin', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yongcheol Kim, MD', 'role': 'CONTACT', 'email': 'yongcheol@yuhs.ac', 'phone': '+823151898967'}, {'name': 'Yongcheol Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Oh Hyun Lee, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ji Woong Roh, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eui Im, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Deok Kyu Cho, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Yongcheol Kim'}], 'centralContacts': [{'name': 'Yongcheol Kim, MD, PhD', 'role': 'CONTACT', 'email': 'yongcheol@yuhs.ac', 'phone': '+823151898967'}, {'name': 'Ji Woong Roh, MD, PhD', 'role': 'CONTACT', 'email': 'NOMGALDA@yuhs.ac', 'phone': '+823151898792'}], 'overallOfficials': [{'name': 'Yongcheol Kim, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Severance Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Yongcheol Kim', 'investigatorAffiliation': 'Yonsei University'}}}}